Company Description
Plus Therapeutics, Inc. (NASDAQ: PSTV) is a clinical-stage pharmaceutical company focused on targeted radiotherapeutics and precision diagnostics for difficult-to-treat cancers of the central nervous system (CNS). Headquartered in Houston, Texas, the company develops radioactive drug formulations and related technologies intended to deliver high-dose, localized radiation to CNS tumors, as well as diagnostic tools that help clinicians detect and manage CNS metastases.
Core Focus: Targeted Radiotherapeutics for CNS Cancers
According to Plus Therapeutics, its primary therapeutic programs center on REYOBIQ™ (rhenium Re186 obisbemeda), a novel injectable radiotherapy designed for CNS tumors. REYOBIQ is being evaluated in clinical trials for recurrent glioblastoma (GBM), leptomeningeal metastases (LM), and pediatric brain cancers. The company describes REYOBIQ as formulated to deliver direct, targeted high-dose radiation within CNS tumors with the goal of optimizing patient outcomes and reducing off-target exposure compared with existing therapies.
Plus Therapeutics reports that REYOBIQ is studied in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health, while ReSPECT-LM is funded by a multi-year grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The ReSPECT-PBC trial for pediatric brain cancer is supported by a grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program. These external grants underscore that the programs are part of broader, publicly supported research initiatives.
Technology and Development Approach
Company disclosures state that Plus Therapeutics is developing targeted radiotherapeutics with advanced platform technologies for CNS cancers. Its work with rhenium-based isotopes, including rhenium-186, is intended to exploit characteristics such as beta energy for tumor cell destruction and gamma energy for real-time imaging. The company describes its approach as combining image-guided local beta radiation with targeted drug delivery methods to concentrate radiation in tumor tissue while limiting systemic exposure.
In regulatory and investor materials, Plus Therapeutics characterizes itself as a U.S. pharmaceutical company whose formulations are designed to achieve elevated patient-absorbed radiation doses and extended retention times within tumors. The aim, as described by the company, is to allow radioactive decay to occur largely within the tumor, which may contribute to lower exposure of normal tissues and potentially improved safety margins.
Diagnostic Subsidiary: CNSide Diagnostics, LLC
Plus Therapeutics owns CNSide Diagnostics, LLC, a wholly owned subsidiary that develops and commercializes proprietary laboratory-developed tests (LDTs) for CNS cancers. CNSide Diagnostics focuses on identifying tumor cells that have metastasized to the CNS in patients with carcinomas and melanomas.
The subsidiary’s flagship offering is the CNSide® Cerebrospinal Fluid (CSF) Assay Platform, including a CSF Tumor Cell Enumeration (TCE) test. Company communications state that CNSide enables quantitative analysis of cerebrospinal fluid to support rapid diagnosis, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases. Plus Therapeutics reports that CNSide has demonstrated high sensitivity and specificity in clinical and real-world settings and has been used at numerous U.S. cancer institutions.
CNSide Diagnostics operates a CLIA-certified laboratory facility in Houston, Texas and provides CNSide testing as a service to U.S. health care professionals. The company notes that state licensure and payor agreements are important components of its market access and launch strategy for the CNSide platform.
Regulatory and Clinical Interactions
Plus Therapeutics frequently reports on its regulatory interactions with the U.S. Food and Drug Administration (FDA) related to REYOBIQ. The company has described Type B meetings with the FDA to discuss pivotal trial strategies for leptomeningeal metastases, including trial design, endpoints such as overall survival, and potential use of circulating tumor cells as secondary endpoints.
In public statements, Plus Therapeutics has also highlighted that REYOBIQ has been granted Fast Track and Orphan Drug designations for certain CNS cancer indications. The company indicates that these designations, along with ongoing dialogue with the FDA, inform its planning for dose optimization and potential pivotal or registrational trials.
Capital Markets and Nasdaq Listing
Plus Therapeutics’ common stock trades on the Nasdaq Capital Market under the ticker symbol PSTV. The company has disclosed multiple capital-raising activities, including a purchase agreement with Lincoln Park Capital Fund, LLC for the potential sale of up to a specified dollar amount of common stock, and an underwritten public offering of units consisting of common stock and warrants.
SEC filings and company press releases note that Plus Therapeutics has received notices from Nasdaq regarding compliance with listing standards, such as the minimum bid price requirement and stockholders’ equity thresholds. The company has reported extensions to regain compliance and has indicated that it may consider actions such as a reverse stock split if needed to meet Nasdaq’s minimum bid price rule. These disclosures provide context for investors monitoring PSTV’s listing status.
Supply Chain and Strategic Partnerships
In its public communications, Plus Therapeutics states that it has built a supply chain through strategic partnerships that support the development, manufacturing, and potential future commercialization of its radiotherapeutic products. While specific counterparties are not detailed in the provided materials, the company emphasizes that these relationships are intended to enable production and distribution of its investigational therapies and diagnostic services.
Business Structure and Sector Classification
Plus Therapeutics is incorporated in Delaware and is categorized under manufacturing-related industry codes in regulatory filings, reflecting its focus on pharmaceutical development and related technologies. However, its own descriptions consistently refer to the business as a clinical-stage pharmaceutical company and a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for CNS cancers.
The company’s activities span:
- Development of CNS-focused radiotherapeutic drug candidates such as REYOBIQ.
- Clinical trials in indications including leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers.
- Operation of CNSide Diagnostics, which provides CNS-focused CSF assay testing services.
- Engagement with regulators, grant-making institutions, and payors to support clinical development and diagnostic adoption.
Investment and Research Considerations
Investors researching PSTV stock typically review Plus Therapeutics’ SEC filings, including Forms 10-K, 10-Q, 8-K, S-1, and proxy statements, along with its clinical trial updates and grant-supported research disclosures. These documents outline the company’s risk factors, capital structure, clinical development plans, and Nasdaq listing considerations.
Because Plus Therapeutics is a clinical-stage company, its future prospects depend on the outcomes of ongoing and planned clinical trials, regulatory decisions, and the adoption of its diagnostic services. Company communications often include forward-looking statements that are subject to scientific, regulatory, and financial uncertainties, as described in its cautionary language.
FAQs about Plus Therapeutics, Inc. (PSTV)
- What does Plus Therapeutics, Inc. do?
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company headquartered in Houston, Texas that develops targeted radiotherapeutics for difficult-to-treat CNS cancers and, through its CNSide Diagnostics subsidiary, offers laboratory-developed tests for detecting and managing CNS metastases. - What is REYOBIQ™?
REYOBIQ (rhenium Re186 obisbemeda) is Plus Therapeutics’ lead investigational radiotherapeutic drug candidate. It is described by the company as a novel injectable radiotherapy formulated to deliver direct, targeted high-dose radiation to CNS tumors, and is being evaluated in clinical trials for recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer. - Which clinical trials are evaluating REYOBIQ?
Company materials state that REYOBIQ is being studied in the ReSPECT-GBM trial for recurrent glioblastoma, the ReSPECT-LM trial for leptomeningeal metastases, and the ReSPECT-PBC trial for pediatric brain cancer. These trials assess safety, dosing, and potential efficacy of REYOBIQ in CNS cancer patients. - What is CNSide Diagnostics, LLC?
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics. It develops and commercializes proprietary laboratory-developed tests, including the CNSide CSF Assay Platform, which is designed to identify tumor cells that have metastasized to the CNS and to provide quantitative cerebrospinal fluid analysis for managing leptomeningeal metastases. - What is the CNSide® CSF Assay Platform?
The CNSide CSF Assay Platform is a diagnostic platform that includes a cerebrospinal fluid Tumor Cell Enumeration test. Plus Therapeutics reports that it supports rapid diagnosis, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases by enabling quantitative analysis of tumor cells in cerebrospinal fluid. - Where is Plus Therapeutics headquartered?
Plus Therapeutics states that it is headquartered in Houston, Texas, where it also operates a CLIA-certified laboratory facility for CNSide Diagnostics. - On which exchange does PSTV trade?
According to SEC filings, Plus Therapeutics’ common stock is listed on the Nasdaq Capital Market under the ticker symbol PSTV. - Has Plus Therapeutics received external grant support?
Yes. Company disclosures indicate that ReSPECT-GBM is supported by an award from the National Cancer Institute, ReSPECT-LM is funded by a multi-year grant from the Cancer Prevention & Research Institute of Texas, and ReSPECT-PBC is supported by a grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program. - What regulatory designations does REYOBIQ have?
Plus Therapeutics reports that REYOBIQ has received FDA Fast Track and Orphan Drug designations in certain CNS cancer indications, including leptomeningeal metastases. - What is the company’s relationship with Nasdaq listing requirements?
SEC filings show that Plus Therapeutics has received notices from Nasdaq regarding compliance with requirements such as minimum stockholders’ equity and the $1.00 minimum bid price. The company has reported grace periods and extensions to regain compliance and has indicated that it may use tools such as a reverse stock split if necessary to meet the minimum bid price rule.